Impact of Exercise Intervention for Patients With Non-alcoholic Fatty Liver Disease

NCT04463667 | Unknown

• 1 other identifier: 202002056RIND
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

In Taiwan, with the westernization of eating habit and lifestyle, metabolic syndrome and non-alcoholic fatty liver (NAFLD) have become very important health issues. This project will therefore study the histological and clinical data of patients with non-alcoholic fatty liver disease and explore the impact of exercise intervention on the hepatic fatty infiltration of the patients. The research strategy will include (1) combining modern artificial big data collection technology to fully monitor the daily life, sleep and exercise patterns of the participants; (2) improving fatty liver and metabolic syndrome through trial-based exercise intervention; and (3) exploring the changes of sleep patterns and intestinal microflora in patients with metabolic liver disease after exercise intervention.

Conditions

Fatty Liver; NAFLD

Keywords

NAFLED

Outcome Measures

Primary Outcomes (1)

• 20% reduction in intrahepatic fat

  We aim to evaluate whether active exercise can help reduce the fat content of the liver. After 24-week exercise intervention, the effect of exercise on the reduction of intrahepatic fat content in cases (active exercise) versus controls (no exercise) will be assessed by MRS/PDFF

  24 weeks.

Secondary Outcomes (1)

• Improvement of intrahepatic fibrosis

  24 weeks

Study Arms (1)

The effects of exercise intervention on fatty liver

EXPERIMENTAL

The effects of exercise intervention on fatty liver and the improvement of the above-mentioned various metabolic indicators, including improvement of sleep patterns and changes of intestinal microflora.

Other: exercise

Interventions

exercise OTHER

Collect all basic information including intrahepatic fat and fibrosis severity, and assign them to the exercise intervention group (n = 80) and the observation group (n = 20) after conditional screening.

The effects of exercise intervention on fatty liver

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• non-alcoholic fatty liver from NTUH employees

You may not qualify if:

• not suitable for exercise (severe cardiovascular disease or severe limb and joint disease), patients with inherited hyperlipidemia (diabetes\> 300 mg / dL or low-density lipoprotein cholesterol\> 190 mg / dL or cardiovascular disease has occurred before the age of 60 )event).
• women exclude pregnancy and breastfeeding.
• liver cancer, AFP\> 20 ng/ml.
• alcohol and drug abusers.
• the use of steroids, sex hormones, immunosuppressants, radiation exposure and chemotherapy within 3 months.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (1)

• Wu CH, Yen KC, Wang LY, Hsieh PL, Wu WK, Lee PL, Liu CJ. Automated Whole-Liver Fat Quantification with Magnetic Resonance Imaging-Derived Proton Density Fat Fraction Map: A Prospective Study in Taiwan. Gut Liver. 2025 Jul 15;19(4):617-626. doi: 10.5009/gnl240408. Epub 2025 Apr 1.

  PMID: 40169393 DERIVED

MeSH Terms

Conditions

Fatty Liver; Non-alcoholic Fatty Liver Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Chun-Jen Liu, Doctor

  Department of Internal Medicine, NTUH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Chun-Jen Liu

Model Details: The investigators will collect all basic information including intrahepatic fat and fibrosis severity, and assign them to the exercise intervention group (n = 80) and the observation group (n = 20) after conditional screening.

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 9, 2020
• Study Start: August 25, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)